• Manager Quality Systems

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10500
  • Responsibilities

    Manager, Quality Systems – Global Product Quality develops, implements and maintains Quality Systems Deviation, Investigation, Corrective and Preventive action and Change Management in a manner that is compliant with regulatory requirements and business needs in terms of documenting, investigating, and managing quality documents and data that support the development, manufacture, and commercial distribution of finished pharmaceutical and medical device.

    • Lead continuous improvement of Quality Systems, such as (CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.
    • Generate Monthly and Quarterly Metrics for periodic Quality Management reviews.
    • Lead and Facilitate Management Review meetings.
    • Identify and support quality systems improvement initiatives by working closely with Global Quality department and other key stakeholders
    • Supports Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
    • Support the TrackWise Global Quality System for Deviation, Investigation, CAPA, Change Management and Complaints design, configuration, validation, maintenance, review and approval of User access and training,
    • Provide leadership in establishing to ensure all documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory compliance requirements.
    • Define and lead quality initiatives and engineering projects to improve quality systems, product quality and process capability.
    • Collaborate with Training Team to ensure TrackWise training curricula are current and accurate
    • Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements.
    • Monitors Quality Systems for trends and notify management of events requiring and immediate action
    • Identify compliance gaps and lead focused teams to resolve compliance issues.
    • Lead department projects of varying complexity.
    • Manage the development, monitoring and maintenance of GMP/QSR standards and processes to ensure compliance with local and federal regulations
    • Interact and influence peers to ensure compliance with internal SOPs and FDA regulations.
    • Maintain current knowledge of GMP Compliance program and of applicable company standard operating procedures for areas of responsibility.
    • Provide guidance on interpretation and application of specified QA/GMP compliance regulations, i.e.: 21 CFR Part 210/211.
    • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
    • Interface with regulatory agencies and participates in compliance audits as required.

    Qualifications

    Required:

    • Bachelor’s Degree 3-5 years of Quality Assurance experience in the pharmaceutical and/or medical device industry
    • Experience in Quality Systems and determining reportability to the FDA and other regulatory agencies
    • Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820)
    • Excellent analytical, problem solving, and troubleshooting skills
    • Proficient in MS Office software, TrackWise
    • Strong interpersonal and communication skills
    • Ability to work in a team environment
    • Ability to multi-task

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

    Disclaimer

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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